A specialty CRO serving pharmaceutical, biopharmaceutical & medical device companies.  
Making Strategic Moves
 
  • Adaptive Design
  • Bayesian and Frequentist Analysis
  • Phase I to Phase IV Trials
  • Device Trials
  • Sample Size Calculations
  • Randomizations
  • Statistical Analysis Plan

 

  BLOG

 
  • Custom Reporting
  • STDM and ADaM Datasets
  • CDISC Conversions
  • CRF Design/Review
  • AE Coding
  • Paper-based DM
  • EDC Study Management

  

 

 

 

  • Direct FDA interaction and presenting at panel meetings
  • Experience in multiple therapeutic areas
  • Device Submission Support; PMA,NDA and 510k
  • Bayesian and Frequentist methods resulting in regulatory approvals
  • Adaptive trial design proficiency and experience


   
 
09/10/2014 - BioWest Conference 2014, Denver, CO September 9th - 10th
10/07/2014 - Outsourcing Clinical Trials New England, Boston, MA October 7th - 8th
10/28/2014 - Musculoskeletal New Ventures Conference, Memphis, TN, October 28th - 29th
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  Biostatistics Consulting & Analysis - Clinical Data Management. Programming Solutions. Report Production.Regulatory Support.  
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